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Simple blood test could spot throat Cancer's return early

NCT ID NCT05582122

Diagnosis Sponsor: UNICANCER Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests whether a blood test that looks for HPV DNA can help monitor patients treated for HPV-related oropharyngeal cancer. The goal is to see if the test can detect cancer recurrence earlier than standard methods, and also reduce the number of routine follow-up visits for patients with negative results. About 420 adults who have completed curative treatment will be followed for up to 5 years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HPV16 circulating DNA test (ddPCR blood test)
What this could lead to
If successful, this blood test could help doctors catch cancer recurrence earlier and reduce the number of follow-up visits for many patients.
What could go wrong
This is a phase 2 trial, so the test may not prove accurate enough for routine use. It only applies to HPV16-positive oropharyngeal cancers, not all throat cancers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 420 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Apr 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient aged 18 years or over 2. Patient with p16 positive Oropharyngeal squamous cell carcinoma (OPSCC) 3. Clinical stage T1-4, N0-3, M0 (stages I-III) 4. Any tobacco status 5. Life expectancy greater than 36 months 6. Positive HPV16 Ct-DNA measured before curative anticancer treatment 7. Treated by any curative treatment 8. Complete response at 3 months after end of treatment, which means: * Undetectable HPV16 Ct-DNA and no residual disease on imaging (group A) or * Undetectable HPV16 Ct-DNA and suspicious imaging but persistent disease excluded by either biopsy or repeated imaging (group B1) or * Positive HPV16 Ct-DNA and no residual disease on imaging but negative HPV16 Ct-DNA on the subsequent assessment. This second test will be done 1-2 months after the first one (group C1). 9. Patient must be affiliated to a Social Security System (or equivalent) 10. Patients must have signed a written informed consent form prior to any trial specific procedures. If the patient is physically unable to give his/her written consent, a trusted person of his/her choice, note related to the investigator or the sponsor, can confirm in writing the patient's consent. Exclusion Criteria: 1. Uncontrolled intercurrent illness that would limit compliance with study requirements. 2. Active invasive malignancy within 3 years of inclusion except for non-invasive malignancies such as non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has/have been surgically cured. 3. Any other HPV induced cancer within 5 years 4. Any condition that may jeopardize the patient participation as well as non-contraception for male and female with child-bearing potential, pregnancy or breast-feeding 5. Patient unwilling or unable to comply with the study protocol and follow-up schedule. 6. Participation in another clinical trial with an investigational medical product during the last 30 days prior to the inclusion and during the present study (except if patient is included in the control arm, with placebo or with a product that have a marketed authorization, used as per the summary of product characteristics (SmPC) for the given indication). 7. Patient deprived of liberty or placed under protective custody or guardianship.

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Conditions

The condition(s) this trial relates to.

oropharynx squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Oropharynx squamous cell carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Antoine Lacassagne - NICE

    ACTIVE_NOT_RECRUITING

    Nice, France

  • CHU De Nîmes ICG

    ACTIVE_NOT_RECRUITING

    Nîmes, France

  • Clinique St Vincent- Réunion

    ACTIVE_NOT_RECRUITING

    Saint-Denis, La Réunion, France

  • Eugène Marquis-Rennes

    RECRUITING

    Rennes, France

  • Georges-François Leclerc

    RECRUITING

    Dijon, France

  • Gustave Roussy

    RECRUITING

    Villejuif, France

  • Hôpital Européen Georges Pompidou

    RECRUITING

    Paris, France

  • ICANS Strasbourg

    RECRUITING

    Strasbourg, France

  • ICO - Site St Herblain

    NOT_YET_RECRUITING

    Saint-Herblain, France

  • ISC Avignon

    RECRUITING

    Avignon, France

  • IUCT Oncopole Toulouse

    RECRUITING

    Toulouse, France

  • Institut Curie - Paris

    NOT_YET_RECRUITING

    Paris, France

  • Institut de cancérologie de Lorraine

    RECRUITING

    Vandœuvre-lès-Nancy, France

  • La Timone-AP-HM Marseille

    RECRUITING

    Marseille, France

  • Oscar Lambret- Lille

    NOT_YET_RECRUITING

    Lille, France

  • TENON - APHP Paris

    RECRUITING

    Paris, France

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